Liquichek Qualitative Urine Toxicology Control is intended for use as an assayed quality control urine to monitor the performance of laboratory procedures for qualitative urine toxicology.

Device Description

Liquichek Qualitative Urine Toxicology Controls are prepared from human urine with added drugs of abuse and metabolites of drugs of abuse, preservatives, stabilizers, and constituents of animal origin. The control is provided in liquid form for convenience.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Liquichek Qualitative Urine Toxicology Control, based on the provided text:

Important Note: The provided document is a 510(k) summary for a clinical toxicology control material. These types of devices (quality controls) are not typically evaluated in the same way as diagnostic devices for patient care. They do not involve human-in-the-loop studies, ground truth establishment by medical experts for diagnostic accuracy, or multi-reader multi-case studies. Their performance is primarily assessed through stability testing to ensure they maintain their intended characteristics over time.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Measured Characteristic)	Reported Device Performance (New Device)
Open Vial Stability	All analytes stable for 30 days stored tightly capped at 2 to 8°C or 18 to 25°C.
Shelf Life	3 Years at 2 to 8°C

Study Proving Device Meets Acceptance Criteria:

The study involved stability testing to determine the open vial stability and shelf life of the Liquichek Qualitative Urine Toxicology Control.

Additional Information on the Study:

Sample size used for the test set and data provenance:
This information is not explicitly provided in the summary. For stability studies, "samples" would refer to batches of the control material tested over time. The document states "All supporting data is retained on file at Bio-Rad Laboratories," indicating the data ownership, but details on the number of batches or individual control units tested are absent. Data provenance is implied to be from Bio-Rad Laboratories' internal testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable for a quality control device. The "ground truth" for a quality control is its known concentration or qualitative presence/absence of analytes, established during manufacturing and validated through analytical testing, not by expert medical review.
Adjudication method for the test set:
This is not applicable for a quality control device. Adjudication methods like 2+1 or 3+1 are used for diagnostic studies involving human interpretation of results, not for the analytical performance of a control material.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done. This type of study relates to diagnostic aids, particularly those with AI components, and is not relevant for a quality control product.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. This device is a biochemical control material, not a software algorithm.
The type of ground truth used:
The "ground truth" for this control material would be the known, manufactured concentrations or qualitative presence/absence of the specific drugs and metabolites added to the human urine matrix. This is established through the manufacturing process and confirmed by analytical methods, rather than expert consensus, pathology, or outcomes data.
The sample size for the training set:
This is not applicable. This device is a physical control material, not a machine learning algorithm that requires a "training set."
How the ground truth for the training set was established:
This is not applicable as there is no training set for this type of device.

Summary

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Summary of Safety and Effectiveness Liquichek Qualitative Urine Toxicology Control

1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1555 Fax:

Contact Person

Maria Zeballos Requlatory Affairs Specialist Telephone: (949) 598-1367

Date of Summary Preparation

October 14, 2003

Device Identification 2.0

Liquichek Qualitative Urine Toxicology Control Product Trade Name:

Drug Mixture Control Common Name:

Class I Classifications:

DIF Product Code:

21 CFR 862.3280 Requlation Number:

Device to Which Substantial Equivalence is Claimed 3.0

Liguichek Qualitative Urine Toxicology Control Bio-Rad Laboratories Irvine, California

Docket Number: K001973

Description of Device 4.0

5.0 Statement of Intended Use

Liquichek Qualitative Urine Toxicology Control is intended for use as an assayed quality control urine to monitor the performance of laboratory procedures for qualitative urine toxicology.

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Comparison of the new device with the Predicate Device 6.0

The new Liquichek Qualitative Urine Toxicology Control contains 3,4-Methylenedioxymethamphetamine (MDMA), and the currently marketed Liquichek Qualitative Urine Toxicology Control (K001973) to which substantial equivalence is claimed does not contain MDMA.

	Bio-Rad Liquichek QualitativeUrine Toxicology Control(New Device)	Bio-Rad Liquichek QualitativeUrine Toxicology Control(Predicate Device K001973)
Characteristics
	Similarities
Intended Use	Liquichek Qualitative Urine Toxicology Control isintended for use as an assayed quality control urine tomonitor the performance of laboratory procedures forqualitative urine toxicology.	Liquichek Qualitative Urine Toxicology Control isintended for use as an assayed quality control urineto monitor the performance of laboratory proceduresfor qualitative urine toxicology.
Form	Liquid	Liquid
Matrix	Urine	Urine
Storage(Unopened)	2-8°C until expiration date	2-8°C until expiration date
Open Vial	30 days at 2 to 8°C or 18 to 25°C	30 days at 2 to 8°C or 18 to 25°C
	Differences
Drugs	Same as the predicate device with the addition of:3,4-Methylenedioxymethamphetamine (MDMA),	11-Nor-Δ-9-THC-9-COOH, Amphetamines,Barbiturates, Benzodiazepines, Benzoylecgonine,Cannabinoids, Cocaine, d-Amphetamine, d-Methamphetamine, Ethanol, Lysergic AcidDiethylamide (LSD), Methadone, Methaqualone,Morphine, Free; Nordiazepam, Nortriptyline,Opiates, Oxazepam, Phencyclidine, Propoxyphene,Secobarbital, Tricyclic Antidepressants (TCA)Does not contain:3,4-Methylenedioxymethamphetamine (MDMA)
Label Warnings	Does not require hazard symbols	Requires hazard symbols

Table 1. Similarities and Differences between new and predicate device.

2.0 STATEMENT OF SUPPORTING DATA

Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek Qualitative Urine Toxicology Control. Product claims are as follows:

2.1 Open vial: All analytes will be stable for 30 days when stored tightly capped at 2 to 8ºC or 18 to 25°C.
2.2 Shelf Life: 3 Years at 2 to 8°C
2.3 Real time studies will be ongoing to support the shelf life of this product.

All supporting data is retained on file at Bio-Rad Laboratories.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine and healthcare. The symbol is composed of three wavy lines that converge at the bottom, representing the flow of health and human services.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 2 2003

Ms. Maria Zeballos, RAC Regulatory Affairs Specialist Bio-Rad Laboratories, QSD Diagnostics Group 9500 Jeronimo Road Irvine, CA 92618-2017

K033366 Re: Trade/Device Name: Liquichek Qualitative Urine Toxicology Control Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: October 14, 2003 Received: October 21, 2003

Dear Ms. Zeballos:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known): K033366

Device Name: Liquichek Qualitative Urine Toxicology Control

Indications for Use:

Liquichek Qualitative Urine Toxicology Control is intended for use as an assayed quality control urine to monitor the performance of laboratory procedures for qualitative urine toxicology.

(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use __ or Over-the Counter use __

Albuth Suin
Division Sign-Off for Jean Cooper

Office of In Vitro Diagnostic Device Evaluation and Safety

210(k)

Regulation Number and Section

§ 862.3280 Clinical toxicology control material.

(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.